Clinical Example (86328)
A 67-year-old female with a history of diabetes mellitus and hypertension presented to the emergency department with a 5-day history of malaise, a nonproductive cough, and low-grade fever (eg, 100.4° F/ 38° C). A SARS-CoV-2 IgG/IgM reagent strip antibody test for COVID-19 was ordered. Blood or serum is collected from the patient for testing.
86328 – Immunoassay for infectious agent antibody(ies), qualitative or semiquantitative, single-step method (eg, reagent strip); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19])
Description of Procedure (86328)
A reagent strip cartridge coated with anti-human monoclonal IgM and IgG antibodies and goat antimouse IgG antibodies is removed from its sealed container. The patient’s blood sample is added to the specimen well, followed by specimen diluent. After the specimen and reagents advance to and react with the test area of the reagent strip, the specimen is read optically, observing the control, IgG and IgM bands. Results are interpreted and reported.
Clinical Example (86769)
A 68-year-old male with a history of coronary artery disease, aortic valve replacement, and lymphoma presented to the emergency department with a 6-day history of malaise, a non-productive cough, and low-grade fever (eg, 100.4° F/38° C). SARS-CoV-2 IgG and IgM antibody tests were ordered to inform diagnosis of acute or convalescent phase of COVID-19. Serum or plasma is collected from the patient for testing.
86769 – Antibody; severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19])
Description of Procedure (86769)
A sample of the patient’s serum or plasma is diluted in buffer and an aliquot of the diluted sample and controls in duplicate are added to a multi-well plate, incubated and washed. Peroxidase-conjugated mouse anti-human IgG and IgM antibodies are added to the sample plate and incubated. A chromogenic substrate is added, incubated, and immediately read at 450 nm using a microtiter plate reader. Results are interpreted and reported.
The following are a few common questions and answers regarding these new SARS-CoV-2 (COVID19) tests.
Question: When are these codes available for reporting?
Answer: Codes 86328 and 86769 are available for reporting beginning April 10, 2020. Contact your third-party payer to determine their guidelines regarding reimbursement.
Question: How do these tests differ from newly released code 87635 for laboratory testing for SARS-CoV-2?
Answer: Code 87635 is reported for respiratory specimens from which DNA/RNA is obtained and analyzed, and it is designed to detect the SARS-CoV-2 virus. The two new serologic codes will be used to identify the presence of antibodies to the SARS-CoV-2 virus.
Question: I am using a standalone device that tests for SARS-CoV-2 IgM and IgG antibodies at the point of care (POCT), which new code should I report?
Answer: While CPT does not specifically address place of service considerations, most POC platforms for SARS-CoV-2 serologic testing are single-step methods (eg, reagent strips). Code 86328 would be the most appropriate code to report this analysis. POC tests for COVID-19 also include nucleic acid analysis, and would be captured with code 87635, Infectious agent detection by nucleic acid (DNA or RNA); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease COVID-19]), amplified probe technique, which was
issued on March 13. Codes selected should accurately describe the service provided.
Question: If my testing device (eg, reagent strip) provides an analysis for two antibody classes on a single-step method assay, do I report code 86328 for each antibody class?
Answer: No, code 86328 should be reported once for each reagent strip assay. If the reagent strip tests for one or multiple antibody classes (eg, IgG and IgM), one unit of service should be reported, regardless of the number of antibodies evaluated and reported on
the reagent strip.
References:
https://www.ama-assn.org/system/files/2020-04/cpt-assistant-guide-coronavirus-april-2020.pdf